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GI-101 + lenvatinib is an investigational **combination therapy** for advanced and metastatic solid tumors. GI-101 is a novel bispecific Fc fusion protein engineered to contain the CD80 ectodomain at its N-terminus and an interleukin-2 variant (IL-2v) at its C-terminus, linked via a human IgG4 Fc region. This molecule is designed to enhance cancer-specific immune responses through dual mechanisms: it activates and proliferates effector T cells and NK cells, while counteracting immunosuppression by inhibiting regulatory T cell (Treg) function within the tumor microenvironment. Lenvatinib is an approved oral small molecule that inhibits multiple tyrosine kinases, notably vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptors (FGFR), leading to reduced tumor angiogenesis and cell proliferation. The combination is under clinical investigation for its ability to potentiate anti-tumor efficacy by targeting both tumor cell signaling and the immune response.
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